Traditional Chinese medicine composition for preventing and / or treating ischemic eye diseases

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for preventing and / or treating ischemic eye diseases. The traditional Chinese medicine composition is prepared from 8 to 20 parts of rhizoma acori graminei, 8 to 20 parts of flos eriocauli, 5 to 15 parts of rhizoma chuanxiong, 5 to 15 parts of herba lycopi, 8 to 20 parts of radix astragali seu hedysari, 5 to 15 parts of radix angelicae sinensis, 5 to 15 parts of rhizoma pinelliae and 5 to 15 parts of radix glycyrrhizae. The traditional Chinese medicine composition has the effects of promoting qi circulation, reducing phlegm, promoting blood circulation, dredging vessels, treating both symptoms and root causes, removing turbidity, removing toxicity, reinforcing qi, nourishing yin and the like, and can effectively prevent and / or treat ischemic eye diseases.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition for the prevention and / or treatment of ischemic eye diseases. Background Technology

[0002] Ischemic eye diseases are a group of diseases caused by insufficient blood supply to the eye. For example, ischemic retinopathy refers to a pathological state caused by long-term insufficient retinal blood flow, leading to persistent hypoxia, microvascular non-perfusion, neurovascular unit dysfunction, and secondary neurodegenerative changes. The occurrence of ischemic retinopathy is mainly related to factors such as large vessel stenosis, retinal microvascular occlusion, impaired blood flow return, neurovascular regulatory imbalance, and reduced choroidal blood supply. Its essence is a long-term pathological state of low perfusion and hypoxia in the retina. Currently, clinical treatment for fundus ischemia caused by vascular stenosis and occlusion mainly uses antiplatelet drugs and statins to prevent and treat the primary disease. However, antiplatelet drugs and statins have certain limitations, such as causing elevated transaminase levels and memory loss, making them intolerable to some individuals. Traditional Chinese medicine, through syndrome differentiation and treatment, focuses on deficiency, phlegm, and blood stasis as key factors in treating arthralgia, and uses methods such as strengthening the spleen and kidneys, replenishing qi and resolving phlegm, and promoting blood circulation and removing blood stasis to intervene in ischemic retinopathy. Traditional Chinese medicine (TCM) believes that the root deficiency is mainly due to damage to Qi, blood, Yin, and Yang, while the manifestations of excess include Qi stagnation, blood stasis, phlegm turbidity, and cold coagulation. Blood stasis is considered a crucial pathogenesis of ischemia, and blood-activating and stasis-removing drugs are most commonly used in treatment, as they are effective and have few adverse reactions. Therefore, developing effective and safe drugs for treating ischemic eye diseases has become an urgent clinical problem.

[0003] Buyang Huanwu Decoction is a classic formula for treating ischemic diseases. It contains Astragalus membranaceus 120g, Angelica sinensis 6g, Paeonia lactiflora 4.5g, Ligusticum chuanxiong 3g, Prunus persica 3g, and Carthamus tinctorius 3g. Astragalus membranaceus is the principal herb, focusing on tonifying the original qi, which is fundamental to improving retinal microcirculation perfusion. Angelica sinensis and Paeonia lactiflora are the assistant herbs, promoting blood circulation and removing blood stasis, targeting blood stasis obstructing the collaterals caused by retinal ischemia. Ligusticum chuanxiong, Prunus persica, and Carthamus tinctorius are the adjuvant herbs, enhancing the blood-activating power, clearing stasis and improving the blood flow state of the fundus microvessels. Although Buyang Huanwu Decoction excels in tonifying qi and activating blood, and is suitable for ischemic retinopathy of the qi deficiency and blood stasis type, its pathogenesis is relatively singular, its blood-activating power is relatively slow, and its ophthalmic targeting is insufficient. Its efficacy is limited for severe ischemia and syndromes involving phlegm and blood stasis, and yin deficiency. It is also limited for cases of "deficiency with excess, and unresolved blood stasis and heat." Possible side effects: may worsen blood stasis, induce headache and eye distension, worsen fundus congestion, and those with a tendency for neovascularization or obvious inflammatory response should pay special attention. Summary of the Invention

[0004] This application provides a traditional Chinese medicine composition that possesses the effects of regulating qi and resolving phlegm, promoting blood circulation and unblocking meridians, addressing both the root cause and symptoms, clearing turbidity and removing toxins, and nourishing qi and yin. It can effectively treat ischemic eye diseases. Application of this traditional Chinese medicine composition can significantly restore the reduced thickness of the retinal INL layer, ONL layer, and the entire retina caused by ischemia, restore retinal thickness, and inhibit neovascularization. It can also inhibit abnormal activation of microglia and improve retinal tissue morphology. The specific scheme is as follows: In a first aspect, this application provides a traditional Chinese medicine composition for the prevention and / or treatment of ischemic eye disease, wherein the raw materials of the traditional Chinese medicine composition include, by weight, 8-20 parts of Acorus tatarinowii, 8-20 parts of Eriocaulon buergerianum, 5-15 parts of Ligusticum chuanxiong, and 5-15 parts of Lycopus lucidus.

[0005] Preferably, the raw materials further include 8-20 parts of Astragalus membranaceus, 5-15 parts of Angelica sinensis, and 5-15 parts of Pinellia ternata by weight.

[0006] Preferably, the active pharmaceutical ingredient further includes 5-15 parts of licorice by weight.

[0007] Among them, Acorus tatarinowii and Eriocaulon buergerianum are the principal herbs. They are pungent and warm, improve eyesight and remove corneal opacity, calm the mind and enhance intelligence, open the orifices and refresh the spirit, and improve retinal ischemia.

[0008] The herbs mentioned above, such as Ze Lan and Chuan Xiong, are assistant herbs. They assist the principal herbs in promoting blood circulation and regulating Qi, reducing swelling and edema, improving varicose veins in the fundus, and relieving retinal edema.

[0009] Astragalus and Angelica sinensis are used as adjuvant herbs. They are sweet and warm in nature, and can invigorate qi and nourish blood, promote diuresis and reduce swelling, nourish retinal ganglion cells, and improve fundus ischemia and edema.

[0010] Pinellia ternata is used as an adjuvant. Combined with other principal and assistant herbs such as Acorus tatarinowii and Lycopus lucidus, it helps to resolve phlegm, clear the meridians, and improve retinal ischemia.

[0011] The licorice mentioned above is used as an adjuvant. It invigorates qi, unblocks the meridians, relieves spasms and pain, and harmonizes the effects of other herbs.

[0012] The preferred principal herbs are Acorus tatarinowii and Eriocaulon buergerianum.

[0013] The preferred ingredients are Ze Lan and Chuanxiong.

[0014] Preferred adjuvant herbs are Astragalus membranaceus, Angelica sinensis, and Pinellia ternata; The preferred ingredient is licorice.

[0015] The sources of each herbal component in the herbal composition are as follows: Sweet flag: The dried rhizome of Acorus tatarinowii Schott, a plant in the Araceae family.

[0016] Eriocaulon buergerianum: The inflorescence with a flowering stem of Eriocaulon buergerianum Körn., a plant in the Eriocaulaceae family.

[0017] Chuanxiong: The rhizome of Ligusticum sinense, a plant in the Apiaceae family.

[0018] Eupatorium: The dried aerial parts of Lycopus lucidus Turcz. var. hirtus Regel, a plant in the Lamiaceae family.

[0019] Astragalus: The root of Astragalus membranaceus (Fisch.) Bunge, a plant belonging to the genus Astragalus in the legume family, and Astragalus mongholicus Bunge.

[0020] Angelica sinensis: The dried root of Angelica sinensis (Oliv.) Diels, a plant of the Apiaceae family.

[0021] Licorice: The root and rhizome of licorice (Glycyrrhiza uralensis Fisch.), a plant belonging to the genus Glycyrrhiza in the legume family.

[0022] Pinellia: The tuber of Pinellia ternata (Thunb.) Ten. ex Breitenb., a plant in the Araceae family.

[0023] In some embodiments, the active pharmaceutical ingredients of the traditional Chinese medicine composition include, by weight parts: 8-20 parts of sweet flag, such as 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, etc.; 8-20 parts of Eriocaulon buergerianum, such as 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, etc.; Use 5-15 parts of Ligusticum chuanxiong, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts, etc. 5-15 portions of Zephyranthes, for example, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 portions, etc. Astragalus membranaceus, 8-20 parts, such as 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, etc.; Angelica sinensis in 5-15 parts, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts, etc. Licorice 5-15 parts, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts, etc.; and, Use 5-15 parts of Pinellia ternata, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0024] In some embodiments, the raw materials of the traditional Chinese medicine composition are in the following proportions by weight: 8-20 parts of sweet flag, such as 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, etc.; 8-20 parts of Eriocaulon buergerianum, such as 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, etc.; Use 5-15 parts of Ligusticum chuanxiong, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts, etc. 5-15 portions of Zephyranthes, for example, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 portions, etc. Astragalus membranaceus, 8-20 parts, such as 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, etc.; Angelica sinensis in 5-15 parts, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts, etc. Licorice 5-15 parts, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts, etc.; and, Use 5-15 parts of Pinellia ternata, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0025] In some embodiments, the raw materials of the traditional Chinese medicine composition include, by weight, 15 parts of Acorus tatarinowii, 15 parts of Eriocaulon buergerianum, 10 parts of Ligusticum chuanxiong, 10 parts of Lycopus lucidus, 15 parts of Astragalus membranaceus, 10 parts of Angelica sinensis, 10 parts of Glycyrrhiza uralensis, and 10 parts of Pinellia ternata.

[0026] Preferably, the Pinellia ternata is processed Pinellia ternata. More preferably, the processed Pinellia ternata is Pinellia ternata prepared with alum.

[0027] Preferably, the traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

[0028] In some embodiments, the traditional Chinese medicine composition includes active pharmaceutical ingredients and pharmaceutically acceptable excipients.

[0029] Preferably, the pharmaceutically acceptable excipients include one or more of the following: diluents, disintegrants, lubricants, excipients, binders, flow aids, fillers, or surfactants.

[0030] More preferably, the diluent includes, but is not limited to, one or more of lactose, starch (e.g., pregelatinized starch), microcrystalline cellulose, sorbitol, mannitol, or inorganic calcium salts.

[0031] More preferably, the disintegrant includes, but is not limited to, one or more of croscarmellose, croscarmellose sodium carboxymethyl cellulose, alginate, and microcrystalline cellulose.

[0032] More preferably, the lubricant includes, but is not limited to, one or more of stearic acid, sodium stearate, magnesium stearate, calcium stearate, polyethylene glycol, talc, and hydrogenated vegetable oil.

[0033] More preferably, the excipient includes one or more of fructose, galactose, mannitol, polyvinyl alcohol, sodium carboxymethyl cellulose, erythritol, or cyclodextrin.

[0034] More preferably, the adhesive includes, but is not limited to, one or more of starch paste, hydroxypropyl methylcellulose, and polyvinylpyrrolidone.

[0035] More preferably, the flow aid includes, but is not limited to, one or more of micronized silica gel, talc, or magnesium trisilicate.

[0036] More preferably, the filler includes one or more of sucrose, bifidose, maltodextrin, silicon dioxide, calcium carbonate, magnesium carbonate, aluminum powder, or phenolic resin.

[0037] More preferably, the surfactant includes one or more of Tween-80, hexadecyltrimethylamine bromide, sodium stearyl sulfonate, or sodium dodecyl sulfate.

[0038] Preferably, the traditional Chinese medicine composition is in the form of tablets, capsules, powders, pills, granules, eye drops, oral liquids, injections, decoctions, medicated wines, ointments, or pastes.

[0039] Preferably, the ischemic eye disease is an ischemic fundus disease.

[0040] Preferably, the ischemic eye disease is selected from ischemic retinopathy, ischemic optic neuropathy, or choroidal ischemia.

[0041] More preferably, the ischemic optic neuropathy is selected from anterior ischemic optic neuropathy or posterior ischemic optic neuropathy.

[0042] More preferably, the ischemic retinopathy is selected from diabetic retinopathy, ocular ischemia syndrome, hypertensive retinopathy, retinal vasculitis, radiation retinopathy, retinal ischemia-reperfusion injury, retinopathy of prematurity, diabetic macular edema, age-related macular degeneration (especially dry type), retinal vein occlusion (including central retinal vein occlusion and / or branch retinal vein occlusion), retinal artery occlusion (including central retinal artery occlusion and / or branch retinal artery occlusion), retinitis pigmentosa, sickle cell anemia retinopathy, choroidal retinopathy, glaucoma, myopic retinopathy (e.g., high myopic retinopathy) or vascular wall inflammation, luminal stenosis or occlusion caused by systemic immune diseases.

[0043] Preferably, the ischemic retinopathy is a phlegm-blood stasis type of ischemic retinopathy.

[0044] More preferably, the choroidal ischemia is selected from posterior ciliary artery occlusion or choroidal artery embolism.

[0045] Preferably, the traditional Chinese medicine composition can be used as a human medicine.

[0046] A second aspect of this application provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising preparing an extract from the raw material by decoction, maceration, percolation, reflux, steam distillation, alcohol extraction or sublimation.

[0047] Preferably, the preparation method includes: soaking Astragalus membranaceus, Angelica sinensis, Lycopus lucidus, Glycyrrhiza uralensis and Pinellia ternata together and then decocting them in water, then adding Acorus tatarinowii, Ligusticum chuanxiong and Eriocaulon buergerianum and continuing to decoct in water, filtering out the liquid as the first decoction, adding water to the dregs and decocting them in water, filtering out the liquid as the second decoction, and combining the two decoctions.

[0048] More preferably, the preparation method includes: mixing Astragalus membranaceus, Angelica sinensis, Lycopus lucidus, Glycyrrhiza uralensis and Pinellia ternata, adding water to cover the herbs by about 1-5 cm, soaking for 15-50 minutes, boiling and then decocting for 10-30 minutes, then adding Acorus tatarinowii, Ligusticum chuanxiong and Eriocaulon buergerianum and continuing to decoct for 3-20 minutes, filtering out the liquid as the first decoction, adding water to the dregs to cover the herbs by about 1-5 cm, boiling and then decocting for 10-30 minutes, filtering out the liquid as the second decoction, and combining the two decoctions.

[0049] In some embodiments, the preparation method includes: S1: Place Astragalus membranaceus, Angelica sinensis, Lycopus lucidus, Glycyrrhiza uralensis, and Pinellia ternata into a clay pot or stainless steel pot. Add water until it covers the herbs by about 1-5 cm (preferably 2-3 cm, e.g., 1, 2, 2.5, 3, 4, 5 cm). Soak for 15-50 minutes (preferably 20-30 minutes, e.g., 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, or 50 minutes). Then bring to a boil over high heat, reduce to low heat and simmer for 10-30 minutes (preferably 20-25 minutes, e.g., 10, 15, 20, 21, 22, 23, 24, 25, or 30 minutes). S2: Add Acorus tatarinowii, Ligusticum chuanxiong, and Eriocaulon buergerianum, and continue to simmer over low heat for 3-20 minutes (preferably 5-10 minutes, such as 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 minutes). After the time is up, turn off the heat, let it sit for a while, and then filter out the liquid as the first decoction. S3: Add water to the dregs until they are about 1-5 cm above the surface (preferably 1-2 cm, such as 1, 2, 3, 4, 5 cm). Bring to a boil over high heat, then reduce to low heat and simmer for 10-30 minutes (preferably 15-20 minutes, such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, or 30 minutes). Filter out the liquid as the second decoction. S4: Mix the first and second decoctions and concentrate them by boiling in water.

[0050] A third aspect of this application provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating and / or preventing ischemic eye diseases.

[0051] Preferably, the ischemic eye disease is an ischemic fundus disease.

[0052] Preferably, the ischemic eye disease is selected from ischemic retinopathy, ischemic optic neuropathy, or choroidal ischemia.

[0053] More preferably, the ischemic optic neuropathy is selected from anterior ischemic optic neuropathy or posterior ischemic optic neuropathy.

[0054] More preferably, the ischemic retinopathy is selected from diabetic retinopathy, ocular ischemia syndrome, hypertensive retinopathy, retinal vasculitis, radiation retinopathy, retinal ischemia-reperfusion injury, retinopathy of prematurity, diabetic macular edema, age-related macular degeneration (especially dry type), retinal vein occlusion (including central retinal vein occlusion and / or branch retinal vein occlusion), retinal artery occlusion (including central retinal artery occlusion and / or branch retinal artery occlusion), retinitis pigmentosa, sickle cell anemia retinopathy, choroidal retinopathy, glaucoma, myopic retinopathy (e.g., high myopic retinopathy) or vascular wall inflammation, luminal stenosis or occlusion caused by systemic immune diseases.

[0055] Preferably, the ischemic retinopathy is a phlegm-blood stasis type of ischemic retinopathy.

[0056] More preferably, the choroidal ischemia is selected from posterior ciliary artery occlusion or choroidal artery embolism.

[0057] Preferably, the treatment and / or prevention of ischemic eye disease includes administering an effective amount of the traditional Chinese medicine composition to a subject in need.

[0058] Preferably, the traditional Chinese medicine composition can restore the reduced retinal thickness (including the thickness of the INL layer, ONL layer and / or the entire retina) caused by ischemic retinopathy, inhibit angiogenesis, inhibit abnormal activation of microglia, and / or improve retinal tissue morphology.

[0059] A fourth aspect of this application provides an application of the traditional Chinese medicine composition described in the first aspect above, the application including: A) Use in the preparation of drugs that increase the thickness of the retina (including the INL layer, ONL layer and / or the entire retina); B) Application in the preparation of drugs that inhibit abnormal activation of microglia in the retina; C) Application in the preparation of drugs that improve retinal tissue morphology; D) Application in the preparation of drugs that inhibit angiogenesis.

[0060] A fifth aspect of this application provides a method for treating and / or preventing ischemic eye disease, the method comprising administering an effective amount of the traditional Chinese medicine composition of the first aspect to a subject in need.

[0061] The administration method includes gastrointestinal administration (e.g., oral administration) or non-gastrointestinal administration (e.g., intravenous injection, intramuscular injection, subcutaneous injection, intradermal injection, eye drops, etc.).

[0062] Preferably, the dosage for human administration includes a crude drug amount of 0.5 g / kg / d to 10 g / kg / d, more preferably 0.8 g / kg / d to 5 g / kg / d, for example 0.5 g / kg / d, 0.6 g / kg / d, 0.7 g / kg / d, 0.8 g / kg / d, 0.81 g / kg / d, 0.816 g / kg / d, 0.817 g / kg / d, 0.82 g / kg / d, 0.9 g / kg / d, 1 g / kg / d, 1.5 g / kg / d, 1.58 g / kg / d, 1.59 g / kg / d, 1.6 g / kg / d, 2 g / kg / d, 2.2 g / kg / d, 2.25 g / kg / d, 2.3 g / kg / d, 3 g / kg / d, 4 g / kg / d, 5 g / kg / d, 6 g / kg / d, etc. Raw drug dosage of g / kg / d, 7 g / kg / d, 8 g / kg / d, 9 g / kg / d or 10 g / kg / d.

[0063] Preferably, the ischemic eye disease is an ischemic fundus disease.

[0064] Preferably, the ischemic eye disease is selected from ischemic retinopathy, ischemic optic neuropathy, or choroidal ischemia.

[0065] More preferably, the ischemic optic neuropathy is selected from anterior ischemic optic neuropathy or posterior ischemic optic neuropathy.

[0066] More preferably, the ischemic retinopathy is selected from diabetic retinopathy, ocular ischemia syndrome, hypertensive retinopathy, retinal vasculitis, radiation retinopathy, retinal ischemia-reperfusion injury, retinopathy of prematurity, diabetic macular edema, age-related macular degeneration (especially dry type), retinal vein occlusion (including central retinal vein occlusion and / or branch retinal vein occlusion), retinal artery occlusion (including central retinal artery occlusion and / or branch retinal artery occlusion), retinitis pigmentosa, sickle cell anemia retinopathy, choroidal retinopathy, glaucoma, myopic retinopathy (e.g., high myopic retinopathy) or vascular wall inflammation, luminal stenosis or occlusion caused by systemic immune diseases.

[0067] Preferably, the ischemic retinopathy is a phlegm-blood stasis type of ischemic retinopathy.

[0068] More preferably, the choroidal ischemia is selected from posterior ciliary artery occlusion or choroidal artery embolism.

[0069] In a sixth aspect of the present application, there is provided a method for increasing retinal thickness, inhibiting abnormal activation of microglia in the retina, inhibiting neovascularization, and / or improving the morphology of retinal tissue, said method comprising administering an effective amount of the traditional Chinese medicine composition described in the first aspect to a subject in need thereof.

[0070] Preferably, the retinal thickness includes the thickness of the INL layer, the ONL layer, and / or the entire retina.

[0071] As used herein, "treatment" includes slowing, interrupting, arresting, controlling, stopping, alleviating, or reversing the progression or severity of a sign, symptom, disorder, condition, or disease after it has begun to develop, but does not necessarily involve complete elimination of all disease-related signs, symptoms, conditions, or disorders.

[0072] As used herein, "prevention" refers to a manner implemented to prevent or delay the occurrence of a disease, disorder, or symptom in an organism.

[0073] As used herein, "effective amount" refers to the amount or dose of the traditional Chinese medicine composition of the present application that provides the desired treatment after being administered to a subject in a single or multiple doses.

[0074] As used herein, "pharmaceutically acceptable" means that it does not significantly stimulate an organism nor inhibit the biological activity and properties of the active substance of the administered product (such as the traditional Chinese medicine composition of the present application).

[0075] As used herein, "subject" can be a human or non-human mammal, or can be a cell, tissue, or organ of a human or non-human mammal. The non-human mammal can be a wild animal, zoo animal, economic animal, pet, laboratory animal, etc. Preferably, the non-human mammal includes, but is not limited to, pigs, cows, sheep, horses, donkeys, foxes, jackals, minks, camels, dogs, cats, rabbits, mice (such as rats, mice, guinea pigs, hamsters, gerbils, chinchillas, squirrels), or monkeys, etc.

[0076] Advantages of the present application: Based on retaining the effects of invigorating qi and promoting blood circulation, the traditional Chinese medicine composition of the present application introduces drugs for resolving phlegm and dredging the orifices and improving eyesight, such as Acorus tatarinowii: waking the mind and opening the orifices, guiding the drug to reach the head and eyes; Eriocaulon buergerianum: specifically entering the liver meridian, improving eyesight and removing nebula; Ligusticum chuanxiong: ascending to the head, improving microcirculation in the eyes directly targeting the eyes. Pinellia ternata: resolving phlegm, improving the microenvironment; Acorus tatarinowii: resolving phlegm and opening the orifices; Lycopus lucidus + Ligusticum chuanxiong: promoting blood circulation without being overly drastic, taking into account phlegm and blood stasis. The pathogenesis coverage is more comprehensive, and the ophthalmic targeting is stronger. It is especially suitable for ischemic retinopathy with intermingled phlegm and blood stasis, such as diabetic retinopathy, retinal vein occlusion and other diseases; at the same time, it avoids the adverse reactions that may be brought by a large dose of qi-invigorating, and is more suitable for long-term intervention. Brief Description of the Drawings

[0077] The embodiments of this application will now be described in detail with reference to the accompanying drawings, wherein: Figure 1 HE staining results of the thickness of each layer of the retina; Figure 2 Statistical analysis results of the thickness of each layer of the retina; Figure 3 GFAP signal staining results; Figure 4 Quantitative results of relative fluorescence intensity; Figure 5 TUNEL staining results; Figure 6 H-score results; Figure 7 The migration ability of HRMECs after different group treatments; Figure 8 Line plots showing the migration ability of HRMECs after different treatment groups, where **, ***, and **** represent the significant differences between each group and the FBS group; Figure 9 : The tube-forming ability of HRMECs after different treatment groups; Figure 10 Bar chart showing the tube-forming capacity of HRMECs after different treatment groups.

[0078] In each figure, ns indicates no significant difference, * indicates p < 0.05, ** indicates p < 0.01, *** indicates p < 0.001, and **** indicates p < 0.0001. Detailed Implementation

[0079] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all of them. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0080] Example 1: Preparation method of traditional Chinese medicine composition Place 15g of Astragalus membranaceus, 10g of Angelica sinensis, 10g of Lycopus lucidus, 10g of Glycyrrhiza uralensis, and 10g of Pinellia ternata into a clay pot, add water to cover the herbs by about 2.5cm, soak for 25 minutes, then bring to a boil over high heat, reduce to a simmer and cook for 22 minutes. Add 15g of Acorus tatarinowii, 10g of Ligusticum chuanxiong, and 15g of Eriocaulon buergerianum to the remaining 10 minutes of the first decoction, continue to simmer over low heat, turn off the heat after the time is up, let it sit for a moment, and filter out the liquid as the first decoction. Add water to the dregs to cover them by about 2cm, bring to a boil over high heat, then reduce to a simmer and cook for 20 minutes, filtering out the second decoction. Finally, combine the two decoctions, mix well, decoct in water, and concentrate to 2g / ml for subsequent experiments.

[0081] Example 2: Preparation method of traditional Chinese medicine composition Place 8g of Astragalus membranaceus, 5g of Angelica sinensis, 5g of Lycopus lucidus, 5g of Glycyrrhiza uralensis, and 5g of Pinellia ternata into a stainless steel pot. Add water until it covers the herbs by about 2.5 cm. Soak for 25 minutes, then bring to a boil over high heat. Reduce heat to low and simmer for 20 minutes. When there are 5 minutes left in the first decoction, add 8g of Acorus tatarinowii, 5g of Ligusticum chuanxiong, and 8g of Eriocaulon buergerianum. Continue to simmer over low heat. After the time is up, turn off the heat, let it sit for a moment, and filter out the liquid as the first decoction. Add water to the dregs until it covers the herbs by about 1 cm, bring to a boil over high heat, then reduce heat to low and simmer for 15 minutes. Filter out the second decoction. Finally, combine the two decoctions and mix well.

[0082] Example 3: Preparation method of traditional Chinese medicine composition Place 12g of Astragalus membranaceus, 8g of Angelica sinensis, 8g of Lycopus lucidus, 8g of Glycyrrhiza uralensis, and 8g of Pinellia ternata into a clay pot. Add water until it covers the herbs by about 3cm. Soak for 20 minutes, then bring to a boil over high heat. Reduce heat to low and simmer for 25 minutes. When there are 8 minutes left in the first decoction, add 12g of Acorus tatarinowii, 8g of Ligusticum chuanxiong, and 12g of Eriocaulon buergerianum. Continue to simmer over low heat. After the time is up, turn off the heat, let it sit for a while, and filter out the liquid as the first decoction. Add water to the dregs until it covers the herbs by about 1cm, bring to a boil over high heat, then reduce heat to low and simmer for 15 minutes. Filter out the second decoction. Finally, combine the two decoctions and mix well.

[0083] Example 4: Preparation method of traditional Chinese medicine composition Place 17g of Astragalus membranaceus, 12g of Angelica sinensis, 12g of Lycopus lucidus, 12g of Glycyrrhiza uralensis, and 12g of Pinellia ternata into a stainless steel pot. Add water until it covers the herbs by about 2cm. Soak for 30 minutes, then bring to a boil over high heat. Reduce heat to low and simmer for 25 minutes. When there are 5 minutes left in the first decoction, add 17g of Acorus tatarinowii, 12g of Ligusticum chuanxiong, and 17g of Eriocaulon buergerianum. Continue to simmer over low heat. After the time is up, turn off the heat, let it sit for a while, and filter out the liquid as the first decoction. Add water to the dregs until it covers the herbs by about 2cm, bring to a boil over high heat, then reduce heat to low and simmer for 20 minutes. Filter out the second decoction. Finally, combine the two decoctions and mix well.

[0084] Example 5: Preparation method of traditional Chinese medicine composition Place 19g of Astragalus membranaceus, 14g of Angelica sinensis, 14g of Lycopus lucidus, 14g of Glycyrrhiza uralensis, and 14g of Pinellia ternata into a clay pot. Add water until it covers the herbs by about 3cm. Soak for 25 minutes, then bring to a boil over high heat. Reduce heat to low and simmer for 20 minutes. When there are 10 minutes left in the first decoction, add 19g of Acorus tatarinowii, 14g of Ligusticum chuanxiong, and 19g of Eriocaulon buergerianum. Continue to simmer over low heat. After the time is up, turn off the heat, let it sit for a while, and filter out the liquid as the first decoction. Add water to the dregs until it covers the herbs by about 1cm, bring to a boil over high heat, then reduce heat to low and simmer for 15 minutes. Filter out the second decoction. Finally, combine the two decoctions and mix well.

[0085] Example 6: Preparation method of traditional Chinese medicine composition Place 20g of Astragalus membranaceus, 15g of Angelica sinensis, 15g of Lycopus lucidus, 15g of Glycyrrhiza uralensis, and 15g of Pinellia ternata into a stainless steel pot. Add water until it covers the herbs by about 2cm. Soak for 20 minutes, then bring to a boil over high heat. Reduce heat to low and simmer for 20 minutes. When there are 5 minutes left in the first decoction, add 20g of Acorus tatarinowii, 15g of Ligusticum chuanxiong, and 20g of Eriocaulon buergerianum. Continue to simmer over low heat. After the time is up, turn off the heat, let it sit for a while, and filter out the liquid as the first decoction. Add water to the dregs until it covers the herbs by about 2cm, bring to a boil over high heat, then reduce heat to low and simmer for 20 minutes. Filter out the second decoction. Finally, combine the two decoctions and mix well.

[0086] Example 7: Preparation method of traditional Chinese medicine composition Place 15g of Astragalus membranaceus, 10g of Angelica sinensis, 15g of Lycopus lucidus, 10g of Glycyrrhiza uralensis, and 9g of Pinellia ternata into a clay pot. Add water until it covers the herbs by about 2.5cm. Soak for 30 minutes, then bring to a boil over high heat. Reduce heat to low and simmer for 25 minutes. When there are 10 minutes left in the first decoction, add 10g of Acorus tatarinowii, 10g of Ligusticum chuanxiong, and 15g of Eriocaulon buergerianum. Continue to simmer over low heat. After the time is up, turn off the heat, let it sit for a while, and filter out the liquid as the first decoction. Add water to the dregs until it covers the herbs by about 2cm, bring to a boil over high heat, then reduce heat to low and simmer for 20 minutes. Filter out the second decoction. Finally, combine the two decoctions and mix well.

[0087] Example 8: Cellular experiments to verify the toxicity, cell growth promotion ability, and inhibition of angiogenesis of the traditional Chinese medicine composition. This embodiment uses retinal microvascular endothelial cells (HRMECs) for experimental verification.

[0088] SD rats were administered the following traditional Chinese medicine composition prepared in Example 1 (abbreviated as TL), Buyang Huanwu Decoction (abbreviated as BY, composed of Astragalus membranaceus 120g, Angelica sinensis 6g, Paeonia lactiflora 4.5g, Ligusticum chuanxiong 3g, Prunus persica 3g, and Carthamus tinctorius 3g), and cilostazol (abbreviated as XL) by gavage three times a day (morning, noon, and evening). The dosage of TL was 9.77 mg / g / day, while those of BY and XL were 14.71 mg / g / day and 30 mg / kg / day, respectively. One week after gavage, serum containing the drug was collected, inactivated at 56°C, filtered through a 0.22 μm filter, and stored at -80°C for later use. Cell proliferation-toxicity was determined by CCK-8 assay to identify the optimal serum concentration containing the drug.

[0089] CCK-8 Experimental Procedures Prepare 100 μL of cell suspension in 96-well plates. Pre-culture the plates in an incubator for 24 hours (37°C, 5%). After aspirating the culture medium and washing with PBS, continue culturing for 12 hours with 5%, 10%, 15%, and 20% serum containing the drug. Add 10 μL of CCK-8 solution to each well and incubate the plates for 2 hours. Measure the absorbance at 450 nm using a microplate reader. Cell viability (100%) = [A(drug-treated) - A(blank)] / [A(0-drug-treated) - A(blank)] * 100 A (Drug Addition): Absorbance of wells containing cells, CCK-8 solution, and drug-containing serum. A (blank): Absorbance of pores containing culture medium and CCK-8 solution, without cells. A (0 drug added): Absorbance of wells containing cells and CCK-8 solution, but without drug-containing serum. The results are shown in Table 1. The cell viability of the traditional Chinese medicine composition (TL) prepared in Example 1 of this application was strongest when the serum concentration of the drug was 10%, the cell viability of Buyang Huanwu Decoction was strongest when the serum concentration of the drug was 5%, and the cell viability of cilostazol was strongest when the serum concentration of the drug was 5% or 10%.

[0090] Table 1. Effects of different concentrations of drug-containing serum on the proliferation of hRMECs (X±s, n = 6) Cell migration ability was further tested using a scratch assay.

[0091] Scratch test procedure HRMECs were seeded into 6-well plates. After cell adhesion, they were divided into five groups: RS, RS+5%XL, RS+5%BY, RS+5%TL, and RS+10%TL, respectively. Once confluence exceeded 80%, the medium was replaced with serum-free ECM medium, and the cells were cultured for another 12 hours. Then, they were cultured at 37°C with 1% O2. After 24 hours of culture, a scratch model was created by vertically drawing a line down the center of the 6-well plate using a 200 μL pipette tip. This was considered time 0. The sections were marked on the plate lids with a marker. Images of the scratch areas were captured and their locations recorded using a fluorescence microscope. The original culture medium was discarded, and the cells were washed twice with PBS. Fresh serum-free ECM medium was then added, and images of the scratch areas were captured at the same locations every 6 hours using a fluorescence microscope. The images were analyzed using ImageJ software.

[0092] The cell migration results showed that different concentrations of drug-containing serum treatment had a significant impact on the migration ability of retinal microvascular endothelial cells (HRMECs) (see [link to study]). Figure 7-8 ).

[0093] Cells migrated fastest in fetal bovine serum (FBS) culture, while cells migrated normally in rat serum (RS, drug-free serum). RS+5%XL, RS+5%BY, and RS+5%TL culture conditions inhibited migration to some extent. RS+10%TL showed the slowest cell migration, indicating that the herbal composition of this application (prepared in Example 1) inhibits the formation of new capillaries, potentially preventing hemorrhage and protecting the retina.

[0094] Further verification was conducted through tube forming experiments, specifically: The experiment began after HRMECs were passaged to the 3rd generation. Cells from passages 3-7 were used in this experiment. Cells were divided into four groups: blank rat serum group (RS group), 5% TL drug-containing serum group (RS+5% TL), 5% BY drug-containing serum group (RS+5% BY), and 5% XL drug-containing serum group (RS+5% XL). Once cell confluence reached 80%, the cells were incubated at 37°C in a 1% O2 incubator for 24 hours. 24-well plates and reduced-volume Matrigel were pre-chilled at 4°C to allow the plates to cool and the Matrigel to liquefy. The procedure was performed on ice, transferring 20 μL of Matrigel to each well of the 24-well plate, ensuring a smooth, bubble-free surface, and incubating overnight at 4°C for leveling. Before the experiment, the 24-well plates were placed in an incubator for 30 minutes to allow the Matrigel to solidify. Cells were grouped, trypsinized, centrifuged, and resuspended. HRMECs were seeded onto the Matrigel at a density of 60,000 cells per well. The cells were then incubated in an incubator, and the tube formation was observed and photographed under a microscope every 2 hours. The analysis was performed using the software ImageJ.

[0095] The tube-forming ability of retinal microvascular endothelial cells (HRMECs) after 24 h of hypoxia treatment was observed using a reduced-dose Matrigel assay with growth factors. Results are as follows: Figure 9-10 As shown, compared with the blank rat serum (RS) group, the drug-containing serum significantly reduced the number of master junctions, master segments, master segment lengths, meshes, and total meshes areas of HRMECs; the effect was most significant in the TL group, where HRMEC tube formation was significantly inhibited, further demonstrating that the traditional Chinese medicine composition of this application (prepared in Example 1) can reduce the formation of new capillaries.

[0096] Example 9: Treatment of ischemic retinopathy 1. Grouping After one week of acclimatization, male SD rats were randomly divided into three groups: a blank control group (n=30), a sham operation group (n=30), and a model group (n=90).

[0097] 2. A rat model of ischemic retinopathy was established by bilateral common carotid artery ligation (BCCAO). Anesthetized rats by intraperitoneal injection of 6 ml / kg tribromoethanol. After satisfactory anesthesia, the rats were fixed in a supine position on the operating table. The skin of the neck, approximately 3*3 cm in size, was shaved and prepared. The neck skin was disinfected with iodine and 75% alcohol. A longitudinal incision of 2-3 cm was made along the midline of the neck. The skin, subcutaneous tissue, muscle layer, and fascia were sequentially cut and separated. The common carotid artery was bluntly dissected between the anterior neck muscles and the right lateral neck muscles, avoiding the vagus nerve. The right common carotid artery was exposed and freed, and ligated with 5-0 silk suture. The left common carotid artery was dissected and ligated in the same way. After the operation, the muscle and skin tissue were sutured with 2-0 silk suture, and the wound was disinfected with alcohol. Postoperatively, ampicillin sodium was administered intramuscularly for 3 consecutive days (50 mg / day) to prevent infection. In the sham-operated group, only the bilateral common carotid arteries were dissected but not ligated; the remaining procedures were the same as in the model group. All rats were fasted for 8-12 hours postoperatively, housed separately, and given free access to water and feed.

[0098] 3. Administration The dosage of the traditional Chinese medicine composition prepared in Example 1 for rats was 9.77 mg / g / d, and the administration method was gavage.

[0099] The control group consisted of the traditional Chinese medicine formula Buyang Huanwu Decoction and the Western medicine cilostazol. The dosages were 14.71 mg / g / day and 30 mg / kg / day, respectively.

[0100] Drug administration began the day after model establishment, with a fixed administration time of 8-10 AM daily. Rats in the sham-operated group and the control group were given the same dose of sterile distilled water by gavage. The observation periods were 14 days, 28 days, and 56 days.

[0101] 4. Pathological observation: Rats were anesthetized intraperitoneally with an overdose of 10% chloral hydrate on postoperative days 14, 28 and 56, respectively.

[0102] Three rats were taken, their chests were opened to expose the heart, and a perfusion needle connected to physiological saline was inserted into the ascending aorta from the apex of the heart. The right atrial appendage was cut open, and 200 mL of 0.9% physiological saline at 20°C and 200 mL of 4% paraformaldehyde at 4°C were rapidly perfused in sequence. The perfusion was stopped after the rat's eyeballs turned white. The skin and fascia around the rat's eyeballs were separated with scissors, the retrobulbar tissue was separated, the optic nerve was cut, and both eyeballs were removed. The tissues around the eyeballs were separated on an ice-cold petri dish, the eyeballs were cut open from the limbus to remove the anterior segment, the vitreous body was preserved, and an eye cup was made.

[0103] HE staining and retinal patch preparation: Paraffin-embedded tissue sections were prepared from one eye cup of three rats and stained with HE. The sections were then observed and photographed under an optical microscope. The degree of retinal damage in each group of rats at different time points after modeling was assessed by measuring retinal thickness and observing the morphology of each retinal layer. Retinal sections photographed under a 40*10x optical microscope were selected. Three fields of view were chosen from each section. The thickness of the retinal total layer (RTL), inner nuclear layer (INL), and outer nuclear layer (ONL) was measured using the FUJI image analysis system. The average value of the results from the three fields of view was taken for statistical analysis. The retinal total layer thickness was defined as the distance between the inner limiting membrane and the outer limiting membrane. Retinal patches were prepared from the other eye of each of the three rats.

[0104] Electron microscopy: The remaining rats were perfused with physiological saline only, without paraformaldehyde perfusion. One eyeball from each of the three rats was used for transmission electron microscopy of the retina.

[0105] Gene sequencing, Western blot (WB), and qPCR: The retinas of the remaining rats were frozen at -80°C. Some were used for gene sequencing, and others were used for Western blot (WB) and qPCR.

[0106] 4. Results Statistics (1) HE staining results Observation under an optical microscope (40*10) revealed that the retinal tissues of the sham-operated rats at each time point exhibited dense, orderly, and clearly defined structures. The retinal ganglion cells (RCGs) were arranged in a single layer with large, deeply stained nuclei that were round or oval. The inner nuclear layer (INL) cells had large, slightly darker nuclei. The outer plexiform layer (OPL) was thinner and discernible. The outer nuclear layer (ONL) was thicker with smaller nuclei, tightly packed cells, and deep staining. The outer lateral membrane (EPL) was clearly visible. The photoreceptor cell layer was orderly and dense.

[0107] In the model group (Model Rats), changes occurred in the retinal tissue structure of various layers at 28 and 56 days. At each time point, the number of cells in the retinal ganglion cell layer was significantly reduced, with condensed and scattered nuclei, observed nuclear chromatin margination, partial cell necrosis, nuclear dissolution, and obvious vacuolar changes. At 56 days, numerous proliferating capillaries appeared in the nerve fiber layer. The distribution of cells in the inner nuclear layer was disordered, and at 56 days, the cells in the inner nuclear layer stained lighter, while the outer nuclear layer became thinner.

[0108] The treatment group (TL group) using the herbal composition of this application showed improvement in the reduction of retinal thickness caused by modeling, as shown in the following results. Figure 1-2 As shown.

[0109] INL Thickness: The INL thickness in the BCCAO group (model group) was significantly lower than that in the Sham group. After using the traditional Chinese medicine composition (BCCAO-TL) of this application, the INL thickness increased significantly and was not significantly different from that in the Sham group.

[0110] ONL Thickness: Compared with the Sham group, the thickness of the outer core layer in the BCCAO group was significantly reduced. After using the traditional Chinese medicine composition (BCCAO-TL) of this application, the thickness of the outer core layer also increased significantly, with no significant difference compared with the Sham group. However, when using the traditional Chinese medicine composition (BCCAO-BY) in the prior art, the thickness of this layer was not improved.

[0111] Retina Thickness: The trend was consistent with INL / ONL. The total retinal thickness in the BCCAO group was significantly lower than that in the Sham group. After using the herbal composition (BCCAO-TL) of this application, the total retinal thickness significantly increased, with no significant difference compared to the Sham group.

[0112] (2) Results of retinal patching On day 56, compared with the sham-operated group (Sham group) rats, the peripheral capillaries of the BCCAO group rats were significantly thinner and small hemorrhages were present.

[0113] The GFAP signal intensity of glial cells in the BCCAO group and those using the existing traditional Chinese medicine composition (BCCAO-BY) was higher, indicating that abnormal activation of microglia in the rat retina occurred after modeling. The existing traditional Chinese medicine composition (BCCAO-BY) could not improve the abnormal activation of microglia, while the GFAP signal intensity of (BCCAO-TL) using the traditional Chinese medicine composition of this application was significantly weaker. Figure 3-4 ).

[0114] (3) TUNEL staining results Compared with the Sham group, the BCCAO group showed a more pronounced trend of increased TUNEL positive signal and structural disorder in the inner nuclear and outer nuclear layers of the retina at 14D, 28D, and 56D. However, the use of the traditional Chinese medicine composition (BCCAO-TL) of this application significantly reduced this positive reaction and improved tissue morphology. Figure 5 ).

[0115] H-score, short for Histochemistry score, is a histological scoring method used in immunohistochemistry. It converts the percentage of positive areas and staining intensity within each section into a numerical value, achieving a semi-quantitative analysis of both the depth and quantity of positive staining in tissue immunohistochemistry. The H-score is calculated as: H-score = (∑(pi×i) = (percentage of weak intensity cells ×1) + (percentage of moderate intensity cells ×2) + (percentage of strong intensity cells ×3), where i represents the positive cell grade: negative (no staining), 0 points; weakly positive (pale yellow), 1 point; moderately positive (brownish-yellow), 2 points; strongly positive (brownish-brown), 3 points. pi represents the percentage of positive cells in the corresponding grade. The H-score ranges from 0 to 300; a higher value indicates a stronger overall positive intensity in terms of both depth and quantity. The results are shown below. Figure 6 As shown, the traditional Chinese medicine composition (BCCAO-TL) of this application can significantly reverse the increase in H-score caused by BCCAO modeling.

[0116] Example 10: Mechanism of the traditional Chinese medicine composition of this application in treating ischemic retinopathy through network pharmacology analysis (1) Screening of active ingredients and targets of traditional Chinese medicine Using the TCMSP and HERB databases, all effective ingredients in Example 7 were screened. The screening was conducted according to oral bioavailability (OB) ≥ 30% and drug similarity (DL) ≥ 0.18. After merging duplicate values, a total of 226 effective ingredients from 8 kinds of traditional Chinese medicines and 244 drug targets were identified in the traditional Chinese medicine composition of this application.

[0117] (2) Collect disease-related targets Using tools / databases: GeneCards, OMIM, DisGeNET, TTD (Therapeutic Target Database), we searched for the disease keyword Ocular Ischemia and set the "Relevance Score" threshold to screen for core targets (>30). Results: A total of 3273 disease-related targets were screened.

[0118] (3) Intersection selection to screen candidate targets Potential therapeutic targets were obtained by taking the intersection of drug targets and disease-related targets. A total of 69 potential therapeutic targets were obtained.

[0119] (4) Protein-protein interaction network analysis (PPI) Using the STRING database, the species was designated as "Homo sapiens", and the confidence score was set to >0.7 (high confidence). A protein-protein interaction network (PPI network) was generated. The PPI network was then imported into Cytoscape plotting software, and the downstream target was screened using the MCODE plugin.

[0120] (5) Enrichment analysis Enrichment analysis was performed using the Metascape platform, including GO enrichment analysis (cellular components, molecular functions, biological processes) and KEGG pathway analysis (screening for signaling pathways related to disease mechanisms). A total of 151 potentially involved pathways and diseases were identified through KEGG pathway analysis. Based on literature review and screening according to enrichment and logP values, key pathways were identified. These pathways, combined with PPI networks, MCODE core genes, and pathway target networks, identified key genes.

[0121] The preferred embodiments of this application have been described in detail above. However, this application is not limited to the specific details of the above embodiments. Within the scope of the technical concept of this application, various simple modifications can be made to the technical solution of this application, and these simple modifications all fall within the protection scope of this application.

[0122] It should also be noted that the various specific technical features described in the above embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, this application will not describe the various possible combinations separately.

Claims

1. A traditional Chinese medicine composition for the prevention and / or treatment of ischemic eye disease, characterized in that, The raw materials of the traditional Chinese medicine composition include, by mass parts, 8-20 parts of Acorus tatarinowii, 8-20 parts of Eriocaulon buergerianum, 5-15 parts of Ligusticum chuanxiong, and 5-15 parts of Lycopus lucidus.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials also include, by weight, 8-20 parts of Astragalus membranaceus, 5-15 parts of Angelica sinensis, and 5-15 parts of Pinellia ternata.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The raw materials also include 5-15 parts of licorice by weight.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials of the aforementioned traditional Chinese medicine composition include, by mass parts, 15 parts of Acorus tatarinowii, 15 parts of Eriocaulon buergerianum, 10 parts of Ligusticum chuanxiong, 10 parts of Lycopus lucidus, 15 parts of Astragalus membranaceus, 10 parts of Angelica sinensis, 10 parts of Glycyrrhiza uralensis, and 10 parts of Pinellia ternata.

5. The traditional Chinese medicine composition according to claim 2 or 4, characterized in that, The Pinellia ternata mentioned is processed Pinellia ternata; Preferably, the prepared Pinellia ternata is Pinellia ternata processed with alum.

6. The traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, The traditional Chinese medicine composition also includes pharmaceutically acceptable excipients; Preferably, the pharmaceutically acceptable excipients include one or more of the following: diluents, disintegrants, lubricants, excipients, binders, flow aids, fillers, or surfactants.

7. The traditional Chinese medicine composition according to any one of claims 1-6, characterized in that, The traditional Chinese medicine composition is in the form of tablets, capsules, powders, pills, granules, eye drops, oral liquids, injections, decoctions, medicated wines, ointments, or pastes.

8. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-7, characterized in that, This includes preparing extracts from raw materials through methods such as decoction, maceration, percolation, reflux, steam distillation, alcohol extraction, or sublimation.

9. The preparation method according to claim 8, characterized in that, The preparation method includes: soaking Astragalus membranaceus, Angelica sinensis, Lycopus lucidus, Glycyrrhiza uralensis and Pinellia ternata together and then decocting them in water. Then, add Acorus tatarinowii, Ligusticum chuanxiong and Eriocaulon buergerianum and continue to decoct in water. Filter out the decoction as the first decoction. Add water to the dregs and decoct them in water. Filter out the decoction as the second decoction. Combine the two decoctions.

10. The use of any one of the traditional Chinese medicine compositions according to claims 1-7 in the preparation of a medicament for treating and / or preventing ischemic eye diseases; Preferably, the ischemic eye disease is selected from ischemic retinopathy, ischemic optic neuropathy, or choroidal ischemia; More preferably, the ischemic optic neuropathy is selected from anterior ischemic optic neuropathy or posterior ischemic optic neuropathy; More preferably, the ischemic retinopathy is selected from diabetic retinopathy, ocular ischemia syndrome, hypertensive retinopathy, retinal vasculitis, radiation retinopathy, retinal ischemia-reperfusion injury, retinopathy of prematurity, diabetic macular edema, age-related macular degeneration (especially dry type), retinal vein occlusion (including central retinal vein occlusion and / or branch retinal vein occlusion), retinal artery occlusion (including central retinal artery occlusion and / or branch retinal artery occlusion), retinitis pigmentosa, sickle cell retinopathy, choroidal retinopathy, glaucoma, myopic retinopathy (e.g., high myopic retinopathy) or vascular wall inflammation, luminal stenosis or occlusion caused by systemic immune diseases; More preferably, the choroidal ischemia is selected from posterior ciliary artery occlusion or choroidal artery embolism.

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